Regulatory Support

MC3 can save you time and money by assisting with all stages of medical device development, including regulatory submissions and transfer to production.  

Capabilities include:

FDA SUBMISSIONS

510(k) – Determine which is most appropriate for your business:

  • Traditional
  • Abbreviated
  • Special

PMA (Premarket Approval Applications)

  • Modular
  • Traditional
  • Streamlined
  • PDP (Product Development Protocol)

IDE (Investigational Device Exemptions)

  • Significant Risk (Submit to FDA)
  • Non-significant Risk

FDA COMPLIANCE 

MC3 Inc. will assure that you maintain compliance with FDA regulatory requirements such as:

  • Reporting Corrections & Removals
  • Submitting MDR/Adverse Events
  • Submitting Annual Reports
  • Submitting Registration and Device Listing Facility
  • Warning Letter Response 483
  • Reviewing Marketing Literature, Labeling, Company Web site

AUDITING          

  • Processed Based Auditing
  • FDA QSR
  • Warning Letter 
  • ISO 13485:2003
  • EN MDD/93/42/EEC

Our auditing services:

  • Help you prepare for an FDA Inspection
  • Develop your internal and supplier program
  • Will serve as your Internal Audit staff (contracted)
  • Conduct Gap Analysis
  • Manage your ISO certificate audits
  • Conduct follow-up audits to Corrective Actions for Warning Letter improvements
  • Are conducted in accordance with MDD, ISO 13485,and QSRs
  • Will conduct Supplier/Contractor audits. We give you confidence that your suppliers are meeting their commitments.

FDA INSPECTION PREPAREDNESS

  • Training
  • Auditing / Gap Analysis
  • Mock FDA Inspections
  • Inspection Coordinator Services

FDA FORM 483/WARNING LETTER RESPONSE

INTERNATIONAL REGULATORY AFFAIRS

  • CE Mark
  • Health Canada
  • Regulatory Correspondent
  • US Agent
  • ISO 13485:2003 CAND/CAS

DUE DILIGENCE